GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1

A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants

An Open-label, Fixed-sequence, Two-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Mitiglinide and Pioglitazone in Healthy Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18-35

Primary endpoints

•Area under concentration-time curve from time 0 to infinity (AUCinf)•Area under concentration-curve from time 0 to the last quantifiable•Cmax

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07444424

Org study IDD7260C00024

Timeline

Milestones

Study first posted2026-03-02actual

Study start2026-03-13actual

Last update posted2026-05-15actual

Primary completion2026-07-02estimated

Study completion2026-07-02estimated

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participants with suitable veins for cannulation or repeated venipuncture.

•All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site.

•Females of childbearing potential must agree to use a highly effective contraception method from enrollment.

•Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial.

•Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg.

Exclusion criteria

•History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:

1. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract

2. Cardiovascular disease

3. Neuromuscular or neurogenic disease

4. Type 1 or type 2 diabetes mellitus

•History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.

•History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder.

•History of malignant neoplastic disease.

•History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

•Any clinically important illness, medical/surgical procedure, or trauma.

•Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.

•Basal calcitonin level ≥ 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).

•Uncontrolled thyroid disease.

•Any positive result on screening for serum human immunodeficiency virus (HIV).

•Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.

•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone.

•Participants who have previously received AZD5004.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Area under concentration-time curve from time 0 to infinity (AUCinf)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

concentration, descriptive

Primary/protocol endpoint

Maximum observed drug concentration (Cmax)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs) and AE of special interest (AESI)

Time frame:Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)]

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Terminal elimination half-life (t½λz)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

Half-life

descriptive

Secondary/protocol endpoint

Terminal rate constant (λz)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

descriptive

Secondary/protocol endpoint

Time to reach maximum observed concentration (tmax)

Time frame:Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

Tmax

descriptive

Secondary/protocol endpoint

Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf)

Time frame:From Day 1 to Day 50

AUC₀–∞

ratio, descriptive

Secondary/protocol endpoint

Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUClast (RAUClast)

Time frame:From Day 1 to Day 50

ratio, descriptive

Secondary/protocol endpoint

Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on Cmax (RCmax)

Time frame:From Day 1 to Day 50

ratio, descriptive

Secondary/protocol endpoint

Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf)

Time frame:From Day 1 to Day 70

AUC₀–∞

ratio, descriptive

Secondary/protocol endpoint

Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUClast (RAUClast)

Time frame:From Day 1 to Day 70

AUC₀–∞

ratio, descriptive

Secondary/protocol endpoint

Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on Cmax (RCmax)

Time frame:From Day 1 to Day 70

Cmax

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.